CK Clinical are recruiting for a Senior Clinical Trial Manager, Early Phase to join a well established and successful pharmaceutical company in Switzerland. This will be a hybrid role, office based in Vaud for three days per week.
As Senior Clinical Trial Manager, Early Phase you will contribute to delivering new medicine to the market through planning, leading and delivering international Phase I & II clinical trials in Oncology. You will ensure that your studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice.
Key duties will include:
- Leading the overall initiation, coordination, implementation and management of international clinical trials at different stages during mission duration
- Leading the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met
- Managing operational and technical aspects of projects including budgeting, timelines and risk management
- Managing and coordinating external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. You may be involved in the selection process, depending on study status
- Establishing study milestones and ensuring accurate tracking and reporting of study metrics and timelines
- Ensuring the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company?s specific SOPs
- Providing operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents
- Design, review and approve of all trial related documentation, and establish trial processes
As Senior Clinical Trial Manager, Early Phase you will require:
- BSc in Life Sciences
- Proven experience of managing early phase Oncology studies in a sponsor company
- Experience in pharmacokinetic studies (eg DDI, ADME) will be useful
- Experience of managing and filing Trial Master Files (Veeva Vault knowledge is a plus)
- Strong negotiation skills, scientific knowledge and involvement
- Experience of contributing to protocols and clinical development plans
Salary around CHF165.000
Entitlement to work in the Switzerland is essential. Please quote reference 54968 in all correspondence.
You must have the right to work in Switzerland.
- Agency: CK Group
- Reference: 54968
Website: CK Group
- Posted: 13th January 2023
- Expires: 10th February 2023